The European Commission issued an article that announces the expiration of the EU-Switzerland Mutual Recognition Agreement (MRA). The article says: “The Mutual Recognition Agreement (MRA) is one of the key… Read More
EU – Switzerland MRA expired
All posts by Sheila OShaughnessy
Additional MHRA guidance for medical device companies
Several guidance documents have been published by the Medicines and Healthcare products Regulatory Agency (MHRA) in December 2020 and subsequently, including guidelines on the UK Responsible Person (UKRP) and UK… Read More
Latest UK MHRA updates on Northern Ireland and EU device regulation guidance
Medtech Insight has just recently published an article on the updated guidance from for the post-Brexit era. The Medicines and Healthcare products Regulatory Agency (MHRA) issued a guidance update on… Read More
Regulation on market surveillance and compliance of products requires EU Authorized Representative for additional legislations
Did you know that the European Commission has issued Regulation (EU) 2019/1020? This regulation on market surveillance and compliance of products lays out updated requirements on the appointment of EU… Read More
New UKCA mark after Brexit
On September 1, 2020, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a new guidance how medical devices will be regulated post-Brexit as of January 1, 2021.… Read More
Brexit and the regulatory situation for the medtech industry
31 January 2020 was a somewhat significant day as the UK formally left the EU at a strategic point in the implementation of the Medical Devices and IVD Regulations (EU)… Read More
News on Brexit
What many may already have expected has now been confirmed. UK Prime Minister Boris Johnson has been forced by the House of Commons to request another delay of Brexit date… Read More
New Guidance for the UK Responsible Person Published
The UK has updated its guidance on the UK Responsible Person. The document is applicable should the UK leave the EU without a deal and includes important details about the… Read More
LRQA to Withdraw Notified Body Services
The UK Notified Body Lloyds Register (LRQA) announced that it will not apply for designation under the medical devices and IVD regulations (MDR and IVDR). The announcement comes at a… Read More
Details about the Regulation of Medical Devices in Case of No-Deal Brexit
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) publishes guidance about registration fees and requirements for a No-Deal Brexit These include, among others, legislative information, information about CE Marking… Read More
Brexit Key Challenges – a Brief Case Study
You may already have asked yourself how Brexit may affect your business. This is a very complex question as it strongly depends on the role of your company, your overall… Read More
What about Brexit?
On June 23, 2016, the United Kingdom (UK) voted for the UK to leave the EU, which is commonly referred to as Brexit. Since then, there has been no clear… Read More